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What Testing Standards Must a Product Undergo for U.S. Medical Device Certification?
Category：行业资讯 Date：2024-09-10 17:09:32 Author: Source:
Each device may require different combinations of these tests, depending on its classification, intended use, and specific risks associated with its use.

For U.S. medical device certification, the product must undergo various testing standards to ensure safety, effectiveness, and compliance with FDA regulations. The specific standards depend on the type of device and its classification, but generally include:7(1).jpg

  1. Biocompatibility Testing:

    • To ensure that materials used in the device are safe for contact with the human body. This is typically guided by ISO 10993 standards.

  2. Electrical Safety Testing:

    • For devices with electrical components, testing must comply with standards such as IEC 60601-1 for medical electrical equipment, which covers safety and essential performance.

  3. Electromagnetic Compatibility (EMC) Testing:

    • To assess how the device interacts with electromagnetic fields, complying with standards like IEC 60601-1-2.

  4. Sterilization Testing:

    • If the device is intended to be sterile, testing must validate the sterilization process and its effectiveness. Standards include ISO 11135 for ethylene oxide sterilization and ISO 17665 for steam sterilization.

  5. Performance Testing:

    • Includes bench testing and functional performance testing to verify that the device performs as intended. This varies by device type and may include tests specific to mechanical, chemical, or biological properties.

  6. Clinical Testing:

    • For higher-risk devices, clinical trials or studies may be required to demonstrate safety and effectiveness. This involves adherence to Good Clinical Practice (GCP) standards.

  7. Packaging and Shelf Life Testing:

    • Ensures that the packaging maintains device integrity and that the device remains safe and effective throughout its shelf life.

  8. Labeling Compliance:

    • Testing to ensure that the labeling meets FDA requirements, including clarity, accuracy, and completeness of instructions for use.

Each device may require different combinations of these tests, depending on its classification, intended use, and specific risks associated with its use.

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